Pregabalin
NDC Package 69986-014-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Pregabalin is a medication used to treat pain caused by nerve damage due to diabetes, shingles (herpes zoster) infection, or spinal cord injury. Marketed by Sinotherapeutics Inc., this product is identified by NDC 69986-014 and is authorized under FDA application ANDA214496.

Identification & Billing

NDC Package Code
69986-014-01
Package Description
30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
Product Code
69986-014
11-Digit Billing Format
69986001401
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pregabalin
Dosage Form
-
Usage Information
This medication is used to treat pain caused by nerve damage due to diabetes, shingles (herpes zoster) infection, or spinal cord injury. This medication is also used to treat pain in people with fibromyalgia. It is also used with other medications to treat certain types of seizures (focal seizures).

Regulatory & Marketing

Labeler Name
Sinotherapeutics Inc.
FDA Application #
ANDA214496
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
11-30-2023
Listing Expiration
12-31-2024
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69986-014-01 identifies a specific commercial package of 30 tablet, film coated, extended release in 1 bottle of Pregabalin, labeled by Sinotherapeutics Inc.. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Sinotherapeutics Inc. on November 30, 2023. The current certification is valid through December 31, 2024.

What are the primary indications for this medication?

This medication is used to treat pain caused by nerve damage due to diabetes, shingles (herpes zoster) infection, or spinal cord injury. This medication is also used to treat pain in people with fibromyalgia. It is also used with other medications to treat certain types of seizures (focal seizures).

How is this Sinotherapeutics Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69986001401. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
69986-014-01
11-Digit CMS (5-4-2)
69986-0014-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.